ALLERNIL-HS _{Eye Drops
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(Olopatadine Ophthalmic Solution IP)

DESCRIPTION:

ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor ofhistamine release from the mast cell,for topical administration to the eyes.
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COMPOSITION:

Each ML Contains :

• Olopatadine Hydrochloride
• eq. to Olopatadine U.S.P.                            0.2mg
• Benzalkonium Chloride Solution I.P.          0.1mg
  (As preservative)
• Sterile Aqueous Vehicle.                              q. s..
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CLINICAL  PHARMACOLOGY

Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamineH1-antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure. Two studies in normal volunteers(totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

Results from an environmental study demonstrated that ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP), when subjects were challenged with antigen both initially and up to 8hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.

INDICATIONS AND USAGE

ALLERNIL-HS (Olopatadine Ophthalmic Solution IP) Eye Drops is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

The recommended dose is one drop in each affected eye twice daily at an interval of 6 to 8 hours.

CONTRAINDICATIONS

ALLERNIL-HS Eye Drops(Olopatadine Ophthalmic Solution IP) is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any component of this product.

ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) is for topical use only and not for injection or oral use.

PRECAUTIONS

Patients should be given the following instructions to prevent contamination the dropper tip and solution, care should betaken not to touch the eyelids or surrounding areas with the dropper tip. The bottle should be kept tightly closed when not in use. if the eye is red, contact lens should not be worn.

ALLERNIL-HS (Olopatadine Ophthalmic Solution IP) Eye Drops should not be used to treat contact lens related irritation. Solution IP) Benzalkonium Chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) before they insert their contact lenses.

Pregnancy

Olopatadine was found not to be teratogenic in rats and rabbits. There are ,however, no adequate and well-controlled studies in pregnant woman. Because animal studies are not always predictive of human responses, this drug should be used in pregnant woman only if the potential benefit o the mother justifies the potential risk to the embryo or fetus. Nursing Mothers.

Olopatadine has been identified in the milk of following oral administration. it is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when ALLERNIL-HS Eye Drops(Olopatadine Ophthalmic Solution IP) is administered to a nursing mother.

Pediatric Use

safety and effectiveness of ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP)pediatric patients below the age of 3 years have not been established .

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTION

ALLERNIL - HS Eye Drops ( Olopatadine Ophthalmic Solution IP) is well tolerated Side effects reported by a minority of patients are headache, Blurred vision, burning or stinging, dry eye, foreign body sensation hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.

STORAGE

Keep in a cool &dark place.Below 250C. Do not allow to Freeze.

SHELF LIFE

24 Months

HOW SUPPLIED

ALLERNIL - HS Eye Drops ( Olopatadine Ophthalmic Solution IP) is supplied in 5 mL poly bottles.
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K-FEN 0.5_‍

(Olopatadine Ophthalmic Solution IP)

 THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.

DESCRIPTION:

K-FEN 0.5 (Ketotifen Ophthalmic Solution)is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes. Ketotifen fumarate is a finely crystalline powder with an empirical formula of C23H23NO5S and a molecular weight of 425.50.
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COMPOSITION:

Each ML Contains :

• Ketotifen Fumarate IP
• Eq. to Ketotifen                       0.5mg
• Benzalkonium Chloride
• Solution IP                              0.05mg
(As preservative)
• Sterile Aqueous Vehicle        q .s.
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INDICATIONS AND CLINICAL USE

K-FEN 0.5 (Ketotifen Ophthalmic Solution)is indicated for :
• treatment of allergic conjunctivitis.

CONTRAINDICATIONS

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing ,

WARNINGS AND PRECAUTIONS

General

For topical use only. Not for injection or oral use.
As with all ophthalmic preparations containing Benzalkonium Chloride, patients are advised not to instill Ketotifen Ophthalmic Solution while wearing soft (hydrophilic) contact lenses. Wearers of soft contact lenses should be instructed to remove lenses prior to instillation of drops and to wait at least ten minutes after instilling Ketotifen Ophthalmic Solution before they insert their contact lenses. 
To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.

Special Populations

Pregnant Women: There are no clinical trials on the use of Ketotifen Ophthalmic Solution in pregnant or nursing women, therefore, Ketotifen Ophthalmic Solution should not be used during pregnancy, except if the benefit justifies the potential risk to the fetus.

Pediatrics (>3years of age):

Ketotifen Ophthalmic Solution is indicated for Use in pediatric patients over the age of 3 years.

ADVERSE REACTIONS

In controlled clinical studies with Ketotifen Ophthalmic Solution, conjunctival injection was the most common ocular adverse reaction related to therapy, with a reported incidence of 7.0%. Headache was the most common non-ocular adverse reaction related to therapy, with a reported incidence of 1.5%. The occurrence of these side effects were generally mild and did not result in discontinuation or interruption of trial medication.
The following ocular adverse reactions related to therapy were reported at an incidence of less than 3%. Itching, dry eyes, burning or stinging, eyelid disorder and discharge.

DRUG INTERACTIONS

If Ketotifen Ophthalmic Solution is used concomitantly with other eye medications, patients should be advised to wait at least 5 minutes between the medications.

DOSAGE AND ADMINISTRATION

The recommended dose is one drop in the affected eye(s) every 8 to 12 hours.

OVERDOSAGE

For management of a suspected overdose, especially accidental oral ingestion, please contact your regional poison control center.  
Oral ingestion of the contents of a 5 mL bottle would be equivalent to 1.25 mg of Ketotifen Fumarate. Clinical results have shown no serious signs or symptoms after the ingestion of up to 20 mg of Ketotifen Fumarate.

CLINICAL PHARMACOLOGY

Mechanism of Action
Ketotifen is a fast acting non-competitive histamine antagonist (H1-receptor). In addition, Ketotifen Ophthalmic Solution, Ketotifen inhibits the release of mediators from mast cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils has also been demonstrated. Additionally, Ketotifen attenuates the effects of PAF and inhibits cAMP phosphodiesterase.
In human conjunctival allergen challenge studies, Ketotifen Ophthalmic Solution was significantly more effective than placebo in preventing ocular itching and redness associated with allergic conjunctivitis. The effect was seen within minutes after administration and lasted up to 12 hours.
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‍Pharmacodynamics                                                                                                                In human conjunctival allergen challenge studies, Ketotifen Ophthalmic Solution was significantly more effective than placebo in preventing ocular itching and redness associated with allergic conjunctivitis. The effect was seen within minutes after administration and lasted up to 12 hours. In a placebo-controlled clinical study designed to evaluate safety, Ketotifen Ophthalmic Solution, administered four times a day for 6 weeks, was shown to be safe and well-tolerated in subjects aged3 years and older.
                                                                                                     

INDICATIONS AND USAGE

K-FEN 0.5 (Ketotifen Ophthalmic Solution) is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.

STORAGE

 Store in dry place at atemperature not exceeding25°C.
Do not allow to Freeze.

SHELF LIFE

24 months.

HOW SUPPLIED

K-FEN 0.5 / 5mL (Ketotifen Ophthalmic Solution) is supplied in 5mL poly bottle.
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